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NCT01337453 · ClinicalTrials.gov registry record
Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy
A clinical trial of Flu-like Symptoms, sponsored by Christine Hunter.
- Completed
- Registry status
- 247
- Enrollment target
- 1
- Study location
NCT01337453: Completed study of Flu-like Symptoms, sponsored by Christine Hunter.
NCT01337453 is a study of Flu-like Symptoms that has completed, run by Christine Hunter. The registered enrollment target is 247 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01337453, a study of Flu-like Symptoms, has completed, sponsored by Christine Hunter.
- COMPLETED
- Registry status
- 247 participants
- Enrollment target
- 1
- Study location
Study Summary
Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic, gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires expertise in dosage calculations and application technique to avoid potential side effects. Most adverse events (AEs) related to BoNT are local and related to its mechanism of action, i.e., paralysis of unwanted muscles. However, systemic AEs may also be observed. Flu-like symptoms (FLS) are well recognized AEs in patients treated with BoNT; however there is a paucity of information regarding the frequency, clinical impact, and associated risk factors of this particular complication. Between December 1989 and May 2003, 1,437 reports of BoNT-related AEs were registered at the Food and Drug Administration (FDA). FLS were reported in 4.6% of serious, and 3.2% of non-serious side effects. In this study, the investigators aim to assess prospectively the frequency, clinical characteristics, and risk factors for development of FLS in a group of patients affected with diverse movement disorders and treated with BoNT type A at the Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC) of Baylor College of Medicine (BCM). The investigators will also assess biomarker of inflammatory response in those patients who develop FLS after treatment with BoNT.
Primary Outcome
The frequency of FLS will be estimated by number of patients and number of Botox treatments
Conditions Studied
Study Locations (1)
Texas
- Baylor College of Medicine, Dept. of Neurology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-07 |
What the finished NCT01337453 record still lists
NCT01337453 is an observational study that tracks outcomes without assigning an intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Flu-like Symptoms appearing as the primary indexed condition, and to 0 interventions.
NCT01337453 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01337453 about?
NCT01337453 is a clinical study titled "Flu-Like Symptoms as a Complication of Botulinum Toxin Therapy". Botulinum toxin (BoNT) has become a revolutionary treatment for many neurological, autonomic, gastrointestinal, genitourinary, and cosmetic disorders. The use of this treatment requires expertise in dosage calculations and application technique to avoid potential side effects. Most adverse events (A...
What is the current status of trial NCT01337453?
This trial is currently completed. The enrollment target is 247 participants. The study started on 2011-04. Estimated completion is 2012-07.
What conditions does trial NCT01337453 study?
This clinical trial studies the following conditions: Flu-like Symptoms.
Who is sponsoring clinical trial NCT01337453?
This trial is sponsored by Christine Hunter, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01337453 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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